Status:
COMPLETED
Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
Lead Sponsor:
Institute of Oncology Ljubljana
Collaborating Sponsors:
Ministry of Higher Education, Science and Technology, Solvenia
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent...
Detailed Description
The purpose of this study is to evaluate new regimen of treatment for its activity in malignant pleural mesothelioma (MPM). The primary objectives of the trial are assessing the treatment toxicity, re...
Eligibility Criteria
Inclusion
- Biopsy-proven diagnosis of malignant pleural mesothelioma
- Inoperable for anatomic or physiological reason
- Measurable and previously unirradiated lesion
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
- Adequate haematopoietic, liver, and kidney function.
- Signed informed consent for participation in the trial
Exclusion
- Significant medical co-morbidity
- Pregnant or lactating women
- History of the cancer in the previous 10 years or breast cancer ever.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01243632
Start Date
December 1 2002
End Date
June 1 2010
Last Update
November 18 2010
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000